Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

BioVectra: $135m boost for microbial CDMO’s Canadian plants

The Mallinckrodt subsidiary will benefit from a Canadian government grant to help expand microbial fermentation sites in Prince Edward Island and Nova Scotia.

In 2014, Mallinkrodt Pharmaceuticals acquired Canadian contract manufacturing organization (CMO) BioVectra as part of its $5.6 billion acquisition of Questcor Pharmaceuticals. The CMO has 64,000 L of fermentation bioreactor capacity across its four manufacturing plants in Atlantic Canada – three in Prince Edward Island and one in Nova Scotia.

Now the sites are set to expand through a CA$144.6 million ($107 million) investment by the company and a CA$37.5 million ($28 million) grant from the Strategic Innovation Fund from the government of Canada.

Image: iStock/SMJoness

The new facilities will be built with zero emission construction materials and is set to create 150 new jobs.

“Canadian companies like BioVectra are creating new jobs and establishing themselves as global leaders in producing lifesaving treatments for serious illnesses that affect millions of people around the world,” Canada’s Prime Minister Justin Trudeau said in a statement.

“Today, we are not only investing in an innovative Canadian business, but also in Canadians and the future prosperity of our country.”

Navdeep Bains, Canada’s minister of Innovation, Science and Economic Development, added: “Our government is investing in BioVectra’s project for more environmentally friendly pharmaceutical manufacturing that will drive innovation in the biologics industry for years to come.

“Together we’re helping BioVectra to scale up and create well-paying jobs right here on Prince Edward Island and in Nova Scotia. This project demonstrates the growing potential of Atlantic Canada’s biotechnology cluster to be a world leader.”